FDA Issues 483 to New England Compounding Center

Just before Hurricane Sandy hit the East Coast, on Friday, Oct. 26, 2012, FDA was in full swing. The agency released a copy of a Form 483 issued to the New England Compounding Center (NECC), which has been under investigation for violating the Federal Food, Drug, and Cosmetic Act. For back story, see the video on PharmTech.com/PharmTechTV regarding the compounding center and its connection to the recent fungal meningitis outbreak.

“FDA observed and has since confirmed contaminated products and listed a number of observations regarding conditions in the clean room at NECC’s Framingham, Massachusetts facility,” states the FDA press release. Specifically, investigators observed problems with the center’s cleanroom maintenance and monitoring program, as well as concerns with sterility of raw materials used in its products.

“The inspection report for NECC has not been completed and is not being shared at this time,” says the release. FDA is still working with the US Centers for Disease Control and Prevention and Massachusetts partners regarding fungal meningitis outbreak and those patients who received NECC’s compounded preservative-free methylprednisolone acetate (80mg/ml), an injectable steroid, according to the release.